Home Blood Pressure Monitoring Trial

June 5, 2015 updated by: St George's, University of London

Community Based Trial of Home Blood Pressure Monitoring With Nurse Led Support in Patients With Stroke or TIA Recently Discharged From Hospital

Design: Community based randomised trial with follow up after 12 months Participants: 360 patients admitted with stroke or TIA within the past 9 months will be recruited from the wards or outpatients and randomly allocated into two groups. All patients will be visited by the specialist nurse at home at baseline when she will measure their BP and administer a questionnaire. The questionnaire and BP will be repeated at 12 months follow-up by another researcher blind as to whether the patient is in intervention or control group.

Intervention: Intervention patients will be given a validated home BP monitor and support from the specialist nurse. Control patients will continue with usual care (BP monitoring by their practice).

Main outcome measures in both groups after 12months: 1.Change in systolic BP 2.Cost effectiveness: Incremental cost of the intervention to the NHS and incremental cost per quality adjusted life year gained.

Study hypothesis. Home blood pressure monitoring with nurse support wil lead to lower blood pressure after 12 months compared with usual GP care

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

High blood pressure in patients with stroke increases the risk of recurrence but management in the community is often inadequate. Home blood pressure monitoring may increase patients' involvement in their care, increase compliance, and reduce the need for patients to attend their GP if blood pressure is adequately controlled. However the value of home monitoring to improve BP control is unclear and there is now a window of opportunity for evaluation before their use becomes widespread in the UK. Furthermore its use in stroke patients presents unique challenges relating to the consequent neurological disability.

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, SW17 0RE
        • St. George's Healthcare Trust
    • Surrey
      • Carshalton, Surrey, United Kingdom, SM5 1AA
        • St. Helier NHS Trust
      • Croydon, Surrey, United Kingdom, CR7 7YE
        • Mayday University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Stroke or TIA in last 9 months
  • Blood pressure above 140/85 when measured more than 1 week after stroke or on anti hypertensive medication

Exclusion Criteria:

  • Severe illness likely to dominate pattern of care
  • Already using home blood pressure monitor
  • Non-English speaking
  • Severe cognitive impairment (AMTS<7)
  • Known secondary hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Behavioral: Control - usual care (BP monitoring by their practice)

Patients will not receive a blood pressure monitor and will continue with usual GP care for hypertension management.

GPs will be sent information about the study design, current guidelines and interpretation of home blood pressure readings.
Experimental: Intervention

Patients will be given a home blood pressure monitor and taught how to use it and how to respond to the readings using a standardised protocol and blood pressure targets. The study nurse will follow up patients at home after a month with additional telephone support according to a defined protocol. Patients will consult their own GP for medication changes when above target.

GPs will be sent information about the study design, current guidelines and interpretation of home blood pressure readings.
Behavioral: Intervention - a validated home BP monitor and support from the specialist nurse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction in systolic blood pressure taken by study team at home visit
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
EQ-5D
Time Frame: 12 months
12 months
Reduction in diastolic blood pressure taken by study team at home visit
Time Frame: 12 months
12 months
Reduction in SBP and DBP taken by study team at home visit
Time Frame: 6 months
6 months
Number of prescribed anti hypertensive medications Number of changes to anti hypertensive medication
Time Frame: 12 months
12 months
FEAR
Time Frame: 12 months
12 months
Incremental cost of the intervention to the NHS and cost per QALY
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St George's, University of London

Collaborators

The Stroke Association, United Kingdom

Investigators

  • Principal Investigator: Sally Kerry, MSc, St George's, University of London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

August 9, 2007

First Submitted That Met QC Criteria

August 9, 2007

First Posted (Estimate)

August 10, 2007

Study Record Updates

Last Update Posted (Estimate)

June 9, 2015

Last Update Submitted That Met QC Criteria

June 5, 2015

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07.0002
  • TSA 2006/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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